Muralidhar M Kulkarni

A randomized Phase III clinical trial to assess the efficacy of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants

Highlights • Pentavalent reassortant rotavirus vaccine was tested for efficacy in infants.• The vaccine (BRV-PV) showed excellent tolerability and a good safety profile.• Primary analysis efficacy was 36% against SRVGE and up to 60.5% against VSRVGE.• The efficacy through 2 years of age was 39.5% (SRVGE) and 54.7% (VSRVGE).• The intent to treat analyses confirmed all the per protocol analyses.

Estimating the effect of childhood socioeconomic disadvantage on oral cancer in India using marginal structural models.

Background: Early life socioeconomic disadvantage could affect adult health directly or indirectly. To the best of our knowledge, there are no studies of the direct effect of early life socioeconomic conditions on oral cancer occurrence in adult life. Methods: We conducted a multicenter, hospital-based, case–control study in India between 2011 and 2012 on 180 histopathologically confirmed incident oral and/or oropharyngeal cancer cases, aged 18 years or more, and 272 controls that included hospital visitors, who were not diagnosed with any cancer in the same hospitals. Life-course data were collected on socioeconomic conditions, risk factors, and parental behavior through interview employing a life grid. The early life socioeconomic conditions measure was determined by occupation of the head of household in childhood. Adult socioeconomic measures included participant’s education and current occupation of the head of household. Marginal structural models with stabilized inverse probability weights were used to estimate the controlled direct effects of early life socioeconomic conditions on oral cancer. Results: The total effect model showed that those in the low socioeconomic conditions in the early years of childhood had 60% (risk ratio [RR] = 1.6 [95% confidence interval {CI} = 1.4, 1.9]) increased risk of oral cancer. From the marginal structural models, the estimated risk for developing oral cancer among those in low early life socioeconomic conditions was 50% (RR = 1.5 [95% CI = 1.4, 1.5]), 20% (RR = 1.2 [95% CI = 0.9, 1.7]), and 90% (RR = 1.9 [95% CI = 1.7, 2.2]) greater than those in the high socioeconomic conditions when controlled for smoking, chewing, and alcohol, respectively. When all the three mediators were controlled in a marginal structural model, the RR was 1.3 (95% CI = 1.0, 1.6). Conclusion: Early life low socioeconomic condition had a controlled direct effect on oral cancer when smoking, chewing tobacco, and alcohol were separately adjusted in marginal structural models.

A screening model for oral cancer using risk scores: development and validation

OBJECTIVE A study was conducted to develop and validate a screening model using risk scores to identify individuals at high risk for developing oral cancer in an Indian population. METHODS Life-course data collected from a multicentre case-control study in India were used. Interview was conducted to collect information on predictors limited to the time before the onset of symptoms or cancer diagnosis. Predictors included statistically significant risk factors in the multivariable model. A risk score for each predictor was derived from respective odds ratios (OR). Discrimination of the final model, risk scores and various risk score cut-offs was examined using the c statistic. The optimal cut-off was determined as the one with good area under curve (AUC) and high sensitivity. Predictive ability of the regression model and cut-off risk score was determined by calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). Models were validated from a bootstrap sample. RESULTS Smoking, chewing quid and/or tobacco, alcohol, a family history of upper aero-digestive tract cancer, diet and oral hygiene behaviour were the predictors. Risk scores ranged from 0 to 28. Area under the receiver operating characteristic (ROC) curve for risk scores was good (0.866). The sensitivity (0.928) and negative predictive value (0.927) were high, while specificity (0.603) and positive predictive value (0.607) were low for a risk score cut-off of 6. CONCLUSION A risk score model to screen for individuals with high risk of oral cancer with satisfactory predictive ability was developed in the Indian population. Validation of the model in other populations is necessary before it can be recommended to identify subgroups of the population to be directed towards more extensive clinical evaluation.

Pre-Hypertension among Young Adults (20– 30 Years) in Coastal Villages of Udupi District in Southern India: An Alarming Scenario

Introduction According to Joint National Committee-7 (JNC-7) guidelines, a systolic blood pressure (SBP) of 120 to 139 mm Hg and/or diastolic blood pressure (DBP) of 80 to 89 mm Hg is considered as pre-hypertension. Existing evidence suggest that the cardiovascular morbidities are increasing among pre-hypertensive individuals compared to normal. Objective To assess the magnitude and factors associated with pre-hypertension among young adults (20–30 years) in coastal villages of Udupi Taluk (an area of land with a city or town that serves as its administrative centre and usually a number of villages), Udupi District, Karnataka state, India. Design Community based cross sectional study Setting 6 (out of total 14) coastal villages of Udupi Taluk, Karnataka state, India. Sample 1,152 young adults (age group: 20–30 years) selected by stratified random sampling in 6 coastal villages of Udupi Taluk, Karnataka state, India Method A semi structured pre-tested questionnaire was used to elicit the details on socio-demographic variables, dietary habits, tobacco use, alcohol consumption, physical activity, family history of hypertension and stress levels. Anthropometric measurements and blood pressure were recorded according to standard protocols. Serum cholesterol was measured in a sub sample of the study population. Multivariate logistic regression was applied to identify the independent correlates of pre-hypertension among young adults (20–30 years). Main Outcome Measures Prevalence, Odds ratio (OR) and adjusted (adj) OR for pre-hypertension among young adults (20–30 years). Results The prevalence of pre-hypertension in the study population was 45.2% (95%CI: 42.4–48). Multivariate logistic regression analysis revealed that age group of 25–30 years (adj OR: 4.25, 95% CI: 2.99–6.05), white collared (adj OR: 2.29, 95% CI: 1.08–4.85) and skilled occupation (adj OR: 3.24, 95% CI: 1.64–6.42), students (adj OR: 2.46, 95% CI: 1.22–4.95), using refined cooking oil (adj OR: 0.53, 95% CI: 0.29–0.95), extra salt in meals (adj OR: 2.46, 95% CI: 1.52–3.99), salty food items (adj OR: 6.99, 95% CI: 3.63–13.48), pre-obese (adj OR: 1.66, 95% CI: 1.03–2.67) and obese (adj OR: 9.16, 95% CI: 2.54, 36.4) were the significant correlates of pre-hypertension. Conclusion In the study population, prevalence of pre-hypertension among young adults (20–30 years) was high (45.2%). Biological (age 25–30 years, pre-obesity and obesity) and behavioral (sedentary occupation, intake of extra salt in meals/salty food and not using refined cooking oil) factors were associated with pre-hypertension. Study emphasizes the need of community based screening of pre-hypertension under National Rural Health Mission. It also provides apt information for the evidence based designing of interventions for lifestyle modifications among high risk young adults in the study area.

Health status of school children in rural area of coastal Karnataka

Introduction: Children are the foundation of a strong and healthy nation. Morbidity among school-going children adversely affects their normal growth and development and hence is a major public health concern. School health program was started as an important component of total health care delivery system in the country with a purpose of addressing the health needs of children. Aim: To assess the morbidity pattern and nutritional status among school children. Materials and Methods: Study design: A cross-sectional study. Study period: 1-year from 1 st July 2012 to 30 th June 2013. Study setting: 14 schools with a total strength of 909 children in a rural area of coastal Karnataka. Data collection: Health examination of the school children was carried out by a trained team. Data regarding anthropometric measurements, refractory error, medical problems and minor ailments were collected using a predesigned proforma. Results: A total of 797 children were examined. Dental caries was the most common ailment observed in 31.86% of children 43.32% of the children were underweight, 53.03% were normal, and 3.65% were overweight for age. Conclusion: The school health program provides a good opportunity to screen, identify and impart education regarding health related issues. The common morbidities found were dental caries, pallor, upper respiratory tract infection and refractory error. Overweight was also observed in the school children and needs to be addressed. There is a scope of providing comprehensive school health services by incorporating dental care.

Study of Clinical Profile and Antibiotic Sensitivity in Paratyphoid Fever Cases Admitted at Teaching Hospital in South India

Context: Globally, there has been an increase in incidence of paratyphoid fever, including paratyphoid fever caused by antimicrobial-resistant strains. Studying the clinical profile and antimicrobial sensitivity of paratyphoid fever would help in early diagnosis, appropriate treatment, rational use of antibiotics and prevent drug resistance. Aim: The aim of the study was to evaluate the clinical profile and sensitivity patterns of antibiotics used in the treatment of paratyphoid fever. Settings and Design: A record-based study was done in tertiary care hospital, South India. Materials and Methods: A retrospective analysis of culture-proven cases of paratyphoid fever was done in a tertiary care hospital. The socio-demographic characteristics, mode of presentation and the sensitivity pattern of isolates from blood culture were recorded. One hundred and ten case files of Salmonella paratyphi were reviewed from the medical records section and the required data (data regarding the clinical profile and antibiotic sensitivity) was collected and analyzed using SPSS version 11.5. Results: Fever was present in all patients. All the cases were sensitive for third-generation cephalosporins, and only 31.8% of the cases were sensitive for quinolones. Sensitivity towards other antibiotics in descending order was as follows: ampicillin 93.6%, chloramphenicol 91.8%, aminoglycosides 90.4% and sulphonamides 76.4%. Conclusions: Research shows that there is increasing resistance to fluoroquinolones and sensitivity to chloramphenicol. Considering the changing trend in the sensitivity pattern, the recommendations of treatment for enteric fever need to be rationalized and re-considered.